After consideration of various comments contributed by the foreign grantee/contractor community, by the U.S. grantee/contractor community to maintain the current NIH policy in this area, and by internal governmental discussions regarding the ramifications and implementation issues for effecting such a policy change, the NIH has decided to maintain its general policy by continuing to allow foreign entities to retain rights in intellectual property developed under NIH funding agreements (grants, cooperative agreements, contracts, subgrants, and subcontracts), consistent with current NIH policies and any other terms and conditions of the specific funding agreement awarded.

The NIH continues to be committed to protecting the U.S. public's interest and improving public health worldwide through effective handling of intellectual property rights for U.S. and foreign grantee/contractors. Accordingly, for subject inventions developed with federal funding, foreign grantees and contractors are reminded to meet their obligations under the funding agreements including the following:

(1) In order for grantees and contractors to elect and retain title to any such subject inventions, grantees and contractors must timely comply with the invention reporting requirements set forth in 37 CFR 401.14. These responsibilities are further detailed at https://s-edison.info.nih.gov/iEdison/timeline.jsp;

(2) Grantees and contractors are expected to take effective steps to achieve practical application of any such subject inventions in a timely manner;

(3) The U.S. Government retains a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world. Accordingly, grantees and contractors must protect the U.S. Government’s interest as set forth in 37 CFR 401.14(f), such as by: (i) citing U.S. Government support within the specification of any U.S. patent application for any subject inventions and (ii) providing the U.S. Government with a confirmatory license for subject inventions; and

(4) If a grantee or contractor grants to any person the exclusive right to use or sell any subject invention in the United States, any products embodying the subject invention or produced through the use of the subject invention will be manufactured substantially in the United States, absent a specific waiver of this requirement granted by the U.S. federal funding agency.

We believe that the current policy protects the U.S. public's interest while not unduly compromising productive research and intellectual property relationships. However, the NIH will continue to monitor this matter. If there is a significant decrease in reporting of subject inventions associated with foreign grantees or contractors receiving federal funding or if any significant public health or safety issues arise related to subject inventions developed by foreign grantees and contractors, the NIH may revisit this policy and consider whether a change will be needed based on the circumstances at that time.